Medical Device Manufacturer · US , Annapolis , MD

Vapotherm, Inc. - FDA 510(k) Cleared Devices

13 submissions · 12 cleared · Since 2000

Official Website

13

Total

12

Cleared

1

Denied

FDA 510(k) Regulatory Record - Vapotherm, Inc. Anesthesiology ✕

13 devices

1-13 of 13

Cleared Apr 13, 2026

Anesthesiology · 116d

Cleared Dec 13, 2022

Anesthesiology · 221d

Cleared Oct 28, 2022

Vapotherm Aerosol Adapter AAA-2

Anesthesiology · 217d

Cleared Aug 25, 2021

Anesthesiology · 282d

Cleared Oct 10, 2019

Palladium High Flow Therapy System

Anesthesiology · 177d

Not Cleared Apr 10, 2018

Precision Flow® HVNI

DEN170001 · QAV

Anesthesiology · 462d

Cleared Oct 07, 2011

PRECISION FLOW(R) - HELIOX

Anesthesiology · 116d

Cleared Feb 08, 2011

Anesthesiology · 90d

Cleared Jul 17, 2008

Anesthesiology · 287d

Cleared Apr 13, 2007

VAPOTHERM MODEL# 2000I AND 2000H

Anesthesiology · 98d

Cleared Aug 30, 2004

VAPOTHERM MODEL#2000I, 200H

Anesthesiology · 11d

Cleared May 30, 2003

VAPOTHERM 2000H

Anesthesiology · 588d

Cleared Aug 24, 2000

VAPOTHERM, MODEL 2000I

Anesthesiology · 199d